This invention relates to a packaging for an elongated medical appliance, such as for instance a catheter or a fiber optic surgical unit which have to be unpacked under sterile conditions, having at least a stem of predetermined shape connected to a handling and connecting hub, said packaging comprising a sealed peel-apart flexible pouch, an elongated support member inside the pouch, said support member being longer than the medical appliance, means for maintaining the stem and means for retaining the hub, said means for maintaining the stem and means for retaining the hub being capable to give way in order to permit withdrawal of the medical appliance.
The known packagings of that kind are designed to protect the medical appliance against the risks of contamination as well as those of shocks and deformation during storage and transit. They are also designed to facilitate withdrawal of the medical appliance in conditions appropriate to preserve sterility, in particular of the portions of the stem which have to be inserted into a patient, and to preserve as well the predetermined shape of the stem.
Within this frame, the sealed flexible pouch protects the medical appliance against the risks of contamination while the support member is intended to maintain the medical appliance and to protect it against shocks, its length being greater than that of the medical appliance in order to avoid that the extremities thereof run through the flexible pouch.
The means for maintaining the stem and retaining the hub on the support member differ as they may be integrated to the support or partly integrated thereto and partly fitted in an adaptable piece essentially intended to maintain the shape of the stem.
When such means are integrated to the support member, they generally consist of grooves the contour of which corresponds to the contour of the stem, and the stem is maintained within these grooves by retaining tongues respectively located on both sides of such grooves, which tongues give way to the stem upon raising thereof. The support member also comprises a hollow housing in which the hub is immobilized in the plane of the support member, withdrawal of the hub being achieved by merely lifting it. Of course, there is needed a different support member for each different shape of the stem and hub.
Upon use of the medical appliance, one person first peels apart the pouch at least up to the level of the hub; another person then grasps the hub and lifts it out of its housing and then extracts the stem from the grooves by pulling it while the first person firmly holds the support member. This operation is relatively difficult to perform and requires quite a good touch to avoid damaging the stem. In addition, on the side opposite to the support member, the stem as well as the hub are not protected against shocks, either during storage or transit or further handling because they are only covered by the flexible pouch.
U.S. Pat. No. 4,779,727 discloses a packaging for a catheter, having a tray and an interchangeable insert located in a recess of the tray. The tray and the insert comprise each a plurality of grooves provided with retaining tabs, and at least one of the grooves of the insert is in line with a groove in the tray for holding a catheter therein. Each groove in the tray is provided with a hub retaining slot. Apart from the fact that it is possible to change the insert in order to accommodate different catheters, the problems are the same as outlined herebefore.
European Patent Application published under No. 0440427A1 discloses a packaging including a tray for accommodating the hub and shaft of a catheter and a curve retention insert for securely retaining a curve portion of the catheter; in order to facilitate the extraction of the catheter, the insert is slidably mounted along the longitudinal axis of the tray and the catheter shaft as well as the curve portion are located in corresponding tracks where they are retained in place by tabs providing a snap-fit retention. Both the tray and the insert are provided with conformations allowing relative immobilization thereof during storage and transit as well as relative mobility thereof upon grasping the hub and pulling it laterally out of the packaging. On this traction movement, the shaft of the catheter begins to slide in its track bringing with it the curve retention insert which slides along the tray up to raising the catheter shaft within its track until it snaps out from beneath the tabs; at this point the catheter shaft and the insert can be removed from the tray, and subsequently the catheter curve can be removed from the insert. As for the previously described materials, there is a substantial risk of damage due to forced extraction from a snap-fit retention arrangement. And here again the catheter is not protected against shocks on the side opposite to the tray and its insert because they are only covered by the pouch.
U.S. Pat. No. 4,262,800 describes a holder for a delicate medical instrument such as a surgical unit, comprising an outline of the instrument, pairs of retainer pegs located about the outline, and elastic bands engaging the pegs to secure the instrument on the holder. This arrangement reduces the risk of damaging the medical instrument upon pulling thereon in order to withdraw it from the holder. However, there is the risk of having the elastic bands flying off in all directions upon pulling on the instrument and it is therefore preferable to take them off one by one before using the instrument. This document outlines, as the previous ones, the importance of the problem of maintaining and freeing the shafts, and more particularly the curved portions of medical appliances such as catheters and the like.
U.S. Pat. No. 3,926,309 describes a two layer packaging for separate articles such as a catheter, disposable glove and rinse container. A plastic sheet is folded to bring its two opposite side edges adjacent, and each end of the folded sheet is sealed to form a first pouch. A closure sheet overlying the plastic sheet including the area in which the two opposite side edges are disposed is then sealed about the perimeter to the first sheet to form a second pouch adjacent the first one. A catheter lies in an unrestrained state in the first pouch and other materials such as a disposable glove and rinse container may lie in the second pouch. It may be noted that there is no means for maintaining and protecting the shape, possibly curved, of the catheter.
In order to unpack the catheter it is necessary to first tear the closure sheet to unseal the first pouch and remove the disposable glove and rinse container, and then to separate the opposite side edges of the folded sheet forming the first pouch to provide access into the pouch and grasp the catheter for removing it from the pouch. Here, shock protection of the catheter is somewhat better but removal of the catheter is not too easy and may cause deformations and damage.
The object of this invention is to seek to simply and economically solve the problems relating to maintaining a medical appliance, to protecting it against shocks during storage and transit, and to removing it from its packaging.